DualityBio, Partner of BioNTech and BeiGene, Files for Hong Kong IPO, Highlighting Several Potential First-in-Class ADCs

China’s clinical-stage antibody-drug conjugate (ADC) startup Duality Biotherapeutics, Inc. has filed for a Hong Kong IPO. The company seeks an undisclosed amount to advance its extensive pipeline of ADCs toward approval. This filing showcases recent IPO activity and potentially expands range of cross-border listings. Meanwhile, the Shanghai-based biotech has developed multiple ADC platforms and created 12 in-house candidates, with half currently in clinical stages.

Duality Biotherapeutics Advances ADC Pipeline with Strategic Partnerships and IPO Plans

Established in 2019, Duality Biotherapeutics has developed a pipeline of 12 internally discovered ADCs, with half already in clinical trials. The company has secured significant partnerships with BioNTech, BeiGene, and Adcendo, potentially worth over $4 billion. Additionally, Duality plans to advance two bispecific ADCs and one autoimmune ADC into human testing by 2026.

Furthermore, the IPO filing reveals new details about Duality’s collaboration with BioNTech. The German drugmaker, which partnered with DualityBio in 2023, seeks to diversify beyond its mRNA vaccine focus. 

Duality Biotherapeutics Highlights BioNTech Partnerships and ADC Programs

Duality Biotherapeutics has identified two BioNTech-partnered ADCs as “core products.” Among these, DB-1303, also known as BNT323, is a HER2-targeted ADC that the company aims to file for accelerated approval by 2025 for endometrial cancer. This ADC is central to Duality’s strategy and is undergoing three potentially registrational trials. BNT323 utilizes a stable, cleavable linker and a topoisomerase-based payload to minimize off-target toxicities while enhancing antitumor efficacy. Besides its primary indication, this ADC has shown activity against other solid tumors, including breast, ovarian, colorectal, and esophageal cancers.

Meanwhile, Duality’s second program, BNT324 (formerly DB-1311), targets B7-H3, a protein linked to tumor progression and overexpressed in several cancers such as non-small-cell lung cancer (NSCLC) and castration-resistant prostate cancer (CRPC). Currently in Phase I/IIa trials, BNT324 is set to be tested both as a monotherapy and in combination with immunotherapies. BioNTech and DualityBio received FDA Fast Track Designation for BNT324/DB-1311 in June of this year. 

Additionally, BNT325 (formerly DB-1305) targets TROP2 for less-explored indications like ovarian cancer and has shown potential for NSCLC, cervical cancer, and triple-negative breast cancer. It is also in a Phase I/IIa study for advanced solid tumors, including NSCLC, with promising early efficacy results. Simultaneously, Merck & Co. is collaborating with Daiichi to develop a competing B7-H3 ADC.

DualityBio Advances Bispecific ADCs and Autoimmune Disease Programs with Innovative First-in-Class Potential

With a half a dozen assets currently in clinical trials, several other candidates are nearing clinical stages, including DB-2304, which focuses on autoimmune diseases. This ADC targets blood dendritic cell antigen 2 (BDCA2), a receptor found on plasmacytoid dendritic cells linked to lupus erythematosus (LE). DualityBio plans to submit investigational new drug (IND) applications for systemic and cutaneous LE within the next six months.

Moreover, the company is advancing two bispecific ADCs, a newer technology aimed at targeting two different epitopes on the same or different antigens. This approach aims to reduce off-target toxicities, overcome drug resistance, and enhance ADC internalization. Among these, DB-1419 is the most advanced. It targets both B7-H3 and PD-L1, delivering a toxic DNA topoisomerase I inhibitor while also modulating T-cell activation. DualityBio expects to dose the first patient in a Phase I/IIa global trial within the next six months.

Duality stated that its BDCA2 and B7-H3/PD-L1 drug candidates have the potential to be first-in-class. However, in other areas, the biotech will enter the market after established leaders, making it crucial to demonstrate the unique advantages of its platform.

DualityBio Targets Niche Market; Unpartnered Asset in High Demand

AstraZeneca and Daiichi Sankyo’s Enhertu has established itself in the ADC market, particularly for HER2-high solid tumors and HER2-low breast cancer. However, DualityBio has identified a unique niche with its own ADC pipeline. The company is focusing initially on endometrial cancer across various HER2 expression levels and has also observed promising activity in ovarian, colorectal, and esophageal cancers.

Additionally, DualityBio’s most advanced wholly owned program is DB-1310, a HER3-targeting ADC candidate. The company believes this unpartnered asset offers “untapped opportunities” to address a wide patient population with minimal dependence on biomarker-based selection and to overcome resistance to existing treatments. Currently in Phase I trials, DB-1310 is set to be evaluated in KRAS-mutant NSCLC. Furthermore, DualityBio plans to test the candidate in combination with AstraZeneca’s Tagrisso (osimertinib) for EGFR-mutated NSCLC patients who have developed resistance to tyrosine kinase inhibitors.

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Author

Bernice Lottering